Trial | NCT03536013  Report issue

Title

Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy
A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy Outcomes

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    182
To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.
The primary objective is to evaluate the efficacy of full thickness placental allograft use in improving back and leg pain, when applied to patients undergoing lumbar microdiscectomy.
Study Started
May 03
2018
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Dec 31
2020
Anticipated
Last Update
May 16
2019

Other Other: Full-thickness placental allograft

A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.

Treatment Experimental

91 patients will undergo a typical lumbar microdiscectomy with the addition of a full-thickness placental allograft after the microdiscectomy has been performed.

Control No Intervention

91 patients will undergo a typical lumbar microdiscectomy without the addition of a full-thickness placental allograft.

Criteria 

Inclusion Criteria:

Ambulatory with radiating low back and leg pain for greater than 6 months prior to surgery with clinical diagnosis of lumbar protruding disc.
Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact.

Exclusion Criteria:

Severe hypertension systolic blood pressure (greater than or equal to 200 mm -Hg or diastolic blood pressure greater than or equal to 182 mm Hg)
BMI greater than 45 kg/m2
Subject has had major surgery at the index level
Is an active smoker or stopped smoking in the last 6 months
Any pain that could interfere with the assessment of index level pain (e.g. pain in any other part of the spine)
Active rheumatoid arthritis
Active, local or systemic malignancy such as lung cancer or leukemia
History of vascular disease or sickle cell anemia
Use of the following medications:

No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)

No systemic treatments that may interfere with safety or efficacy assessments during the study
No immunosuppressants

No use of corticosteroids

Subject is pregnant or plans to become pregnant within 24 months of treatment
Subject does not provide full consent
Personal injury, workman's compensation or other legally-related treatment patients.
No Results Posted